On March 9, 2020, FDA issued a new Constituent Update and FDA In Brief on the release of results from FDA’s sampling assignment with AMA Analytical Services, Inc. (AMA) testing talc-containing cosmetic products for the presence of asbestos.
On February 4, 2020, FDA held a public meeting on testing methods for asbestos in talc and cosmetic products containing talc.
On October 18, 2019, the FDA updated the Safety Alert and issued a new Constituent Update warning consumers not to use certain cosmetic products tested positive for asbestos.
The FDA continues to analyze cosmetics for asbestos contamination and will provide updates with additional information that becomes available.
Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos.
FDA's Authority Over Cosmetic Safety
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. The law does not require cosmetic companies to share safety information with FDA.
FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use. Learn more about FDA's Authority Over Cosmetics.
Talc: What it is and How it is Used in Cosmetics
Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2.
Talc has many uses in cosmetics and other personal care products. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.
Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc in the genital area and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. The FDA has ongoing research in this area. In addition, questions about the potential contamination of talc with asbestos have been raised since the 1970s.
Asbestos: What it is, Why it is a Concern, and How to Prevent its Occurrence in Cosmetics
Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen when inhaled. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently.
Public Meeting on Standards and Methods for Testing for Asbestos in Cosmetic Products Containing Talc
The FDA opened a public docket and held a public meeting on February 4, 2020, to discuss and obtain scientific data and information on topics related to cosmetic products with talc as an ingredient, specifically, testing methodologies, terminology, and criteria that could be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in such products. The meeting included presentations by members of an interagency working group (the Interagency Working Group on Asbestos in Consumer Products or IWGACP).
The FDA made available, as part of the meeting materials, an Executive Summary titled “Preliminary Recommendations on Testing Methods for Asbestos in Talc and Consumer Products Containing Talc” by the IWGACP. Neither the Executive Summary nor any of the presentations at the public meeting by members of the IWGACP, represent proposed or preliminary recommendations or policies of the FDA or any other federal agency. The Executive Summary and related presentations at the public meeting were meant solely to solicit scientific feedback on the issues raised and should not be used for any other purpose.
The FDA and members of the IWGACP continue to evaluate the science and public feedback to the docket. The FDA does not have any recommendations at this time. Should the FDA decide to develop recommendations with respect to standards or testing methods for asbestos in talc, as a result of the information it received as part of the public meeting and comments to the public docket or otherwise, it would issue draft guidance for public comment. Likewise, the FDA would propose any related regulations through a public notice and comment process.
- FDA’s formation of an interagency working group on asbestos in consumer products in the fall of 2018. The purpose of this government work group is to develop recommendations on topics related to testing methodologies, terminology, and criteria for data interpretation that can be applied to characterize mineral fibers present as contaminants in consumer products.
- Joint Institute for Food Safety and Applied Nutrition (JIFSAN) scientific/technical meeting. On November 28, 2018, FDA and other government agency representatives attended a scientific and technical symposium designed to provide a forum for scientists to share their knowledge and experience in testing methods for analysis of talc, developing criteria used for fiber identification, and interpreting data. The full transcripts from the symposium can be found below:
- JIFSAN Symposium Asbestos in Talc Main Session Transcript (PDF - 1.1MB) November 28, 2018
- JIFSAN Symposium Asbestos in Talc Breakout Session A Transcript (PDF - 490KB) November 28, 2018
- JIFSAN Symposium Asbestos in Talc Breakout Session B Transcript (PDF - 292KB) November 28, 2018
- JIFSAN Symposium Asbestos in Talc Breakout Session C Transcript (PDF - 397KB) November 28, 2018
The FDA sampled cosmetic products following reports of asbestos contamination in talc-containing cosmetics. Testing of the samples was conducted on behalf of FDA by the Occupational Safety and Health Administration (OSHA) and AMA Analytical Services, Inc. (AMA).
Listed below are the current findings from the testing:
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 1 (D-30 to D-31) (PDF – 4.6 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 2 (D-32 to D-39) (PDF – 39.9 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 3 (D-40 to D-47, D-51 to D-52) (PDF – 56.7 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 4 (D-49 to D-50) (PDF – 33.5 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 5 (D-53 to D-67) (PDF – 76.7 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Final Report Part 6 (D-68 to D-82) (PDF – 86.4 MB) Posted March 9, 2020
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Johnson & Johnson – Baby Powder Lot #22318RB (PDF - 7.68MB) October 11, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Timeless Beauty Palette (PDF - 8MB) August 30, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Matte Blush in Fuchsia (PDF - 8MB) August 30, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Shimmer Bronzer in Caramel (PDF - 5MB) August 30, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus – Bronzer in Sunset (PDF - 7MB) August 30, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Beauty Plus (PDF - 11MB) April 30, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis – Claire’s (PDF - 2MB) April 30, 2019
- OSHA Evaluation of Cosmetics and Cosmetic Talc for FDA (PDF- 2.6 MB) February 23, 2019
- AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis (PDF - 3.9MB) February 21, 2019
The summary table , “FDA Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics of Asbestiform Fibers by AMA Laboratories During FY19”, can be found in 2019 Talc Survey Appendix, which provides further details on the above AMA Analytical Services Inc. reports for each of the cosmetic products containing talc that were analyzed in this survey, including product distributor/manufacturer, brand, product name, batch/lot #, FDA Sample ID # (D-#), and the findings from the testing.
FDA contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct a laboratory talc survey, based on demonstrated experience with asbestos analysis in complex matrices, appropriate facilities, equipment, personnel, analytical strategy, and budget criteria. The study ran from September 28, 2009 to September 27, 2010.
How the Survey Was Conducted
The first step was to identify cosmetic talc suppliers and talc-containing cosmetic products. We found seven talc suppliers identified in the 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and two more by searching online. The contract laboratory contacted each supplier to request samples of its talc. Of the nine suppliers identified, four complied with the request.
We found talc-containing cosmetic products to analyze by visiting various retail outlets in the Washington, D.C. metropolitan area. The samples identified for testing included low, medium, and high priced products, along with some from “niche” markets, in order to cover as broad a product range as possible. A total of thirty-four cosmetic products containing talc were selected, including eye shadow, blush, foundation, face powder, and body powder. All cosmetic products were purchased from retail stores in the Washington, D.C. metropolitan area.
The contract laboratory analyzed the samples using polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods published by the New York State Department of Health, Environmental Laboratory Approval Program. Each sample was analyzed three times using both methods.
The Results of FDA's Survey and What They Mean
The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested. For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination. As always, when potential public health concerns are raised, we will continue to monitor for new information and take appropriate actions to protect the public health.
The tables, found in 2010 Talc Survey Appendix, provide details for each of the cosmetic-grade raw material talc samples and cosmetic products containing talc that were analyzed in this survey. Limits of detection are shown below the table for each group of samples. Note: “NAD” means “no asbestos detected.”